A Clinical Feasibility Study of the Aquea Intracanalicular Glaucoma Micro-coil Stent (NCT07698353) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Clinical Feasibility Study of the Aquea Intracanalicular Glaucoma Micro-coil Stent
Panama29 participantsStarted 2024-04-17
Plain-language summary
The purpose of this research study is to evaluate the safety and effectiveness of the Aquea Intracanalicular Glaucoma Stent in lowering intraocular pressure (IOP) in patients with cataract and open angle glaucoma.
The main questions it aims to answer are:
* What proportion of eyes will have a ≥ 20% decrease in IOP from the hypotensive medication-free baseline examination to the hypotensive medication-free 12-month postoperative examination.
* What is the mean change in IOP between the hypotensive medication-free baseline examination and hypotensive medication-free 12-month postoperative examination.
Participants will be screened for eligibility.
* Eligible subjects will be examined preoperatively to obtain a medical history and to establish a baseline for their ocular condition.
* Subjects will undergo implantation of the Aquea Intracanalicular Glaucoma Stent in one eye in conjunction with cataract surgery.
* Postoperatively, subjects will undergo evaluation at regularly scheduled intervals.
Who can participate
Age range
45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Individuals 45 years of age or older, of either gender or any race, at the time of surgery.
. Able to understand the requirements of the study and willing to follow study instructions, provide written informed consent, and agree to comply with all study requirements, including the required study follow-up visits.
. A diagnosis of cataract eligible for phacoemulsification cataract extraction and IOL implantation.
. A diagnosis of primary open angle glaucoma (POAG) substantiated using funduscopic exam and at least one reliable visual field test (i.e., Mean Deviation \[MD\] \< 0 with fixation losses ≤ 30%, false positive errors ≤ 30% and false negative errors ≤ 30%) with the Humphrey automated perimeter using the SITA Standard 24-2 testing algorithm.
. At the Screening Visit, medicated IOP of ≤ 25 mmHg or unmedicated IOP of ≥ 21 mmHg and ≤ 33 mmHg.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is studying a device called the Aquea Intracanalicular Glaucoma Micro-coil Stent — can you explain how this stent works inside the eye's drainage canal and how it's different from other glaucoma devices or surgeries I might already know about?
2The trial is listed as 'active but no longer recruiting,' which means I couldn't enroll even if I wanted to — so are there similar early-stage device trials currently open that might be worth looking into, or is a standard surgical option like a trabeculectomy or an already-approved MIGS device a better path for me right now?
3Since this is listed as a feasibility study with no assigned phase, that tells me the researchers are still figuring out whether this device even works well enough to study further — given that uncertainty, how does the risk-benefit picture here compare to treatments that already have more safety and effectiveness data behind them?
4My situation involves both open-angle glaucoma and cataracts — can you help me understand whether those two conditions together would have made someone a candidate for this kind of combined procedure trial, and what that might mean for how my own treatment plan should be structured?
5The trial's primary goal is something called a 'Primary Effectiveness Endpoint' without a lot of detail shared publicly — what questions should I be asking the trial team or reviewing in the consent documents to really understand what they were measuring and what early results, if any, have been shared?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. At the Baseline Visit, a mean unmedicated IOP of ≥ 21 mmHg and ≤ 33 mmHg. The mean will be derived from the diurnal IOP readings taken over the course of the Baseline Visit day. Additionally, the baseline mean unmedicated diurnal IOP must be ≥ 3 mmHg higher than the medicated IOP measured at the Screening Visit.
. No changes in preoperative ocular hypotensive medication regimen for at least three months prior to Screening Visit.
. Gonioscopy confirming normal angle anatomy at site of implantation.
Exclusion criteria
. Inability to complete a reliable 24-2 SITA Standard Humphrey visual field on the study eye at Screening (fixation losses, false positive errors and false negative errors should not be greater than 30%).
. Use of more than 3 ocular hypotensive medications. (Combination medications count as 2 or 3 medications depending on number of active ingredients.)
. Use of oral hypotensive medication treatment for glaucoma in the fellow eye.
. Significant risk by a washout of medication including those subjects with advanced glaucoma evidenced by an afferent pupillary defect, a C:D ratio ≥ 0.9 or encroachment of field loss within the central 5 degrees as indicated by ≥ 2 depressed points of 0.5% probability on the 24-2 SITA Standard Humphrey visual field.
. Previous glaucoma procedure with or without an implantable glaucoma device (with exception of laser treatments to the trabecular meshwork such as a Laser Trabeculoplasty performed more than three months prior to study enrollment).
. Proliferative or severe nonproliferative diabetic retinopathy.